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Health Canada has more to do to restore confidence on drugs: Editorial

There’s much more Health Canada must do to assure Canadians it is acting as a vigilant protector of our health on prescription drugs.

After weeks of foot-dragging, Health Canada has at last moved to ban the import of more than 30 drugs and 30 drug ingredients from two factories operated by Toronto-based Apotex Inc. in Bangalore, India. (Sean Kilpatrick / THE CANADIAN PRESS)

Wed., Oct. 1, 2014

It took almost three weeks, a campaign by the Star and a drumbeat of criticism in Parliament, but federal Health Minister Rona Ambrose is finally standing up for consumers and pushing back against drug companies that fall short of safety standards.

That’s a positive — if overdue — first step. But there’s much more the government and Health Canada must do to assure Canadians that they are acting as vigilant protectors of our health.

After weeks of foot-dragging, Ambrose announced on Tuesday that her department had at last moved to ban the import of more than 30 drugs and 30 drug ingredients from two factories operated by Toronto-based Apotex Inc. in Bangalore, India.

A Star investigation by reporters David Bruser and Jesse McLean had revealed the company was producing drugs and drug products that had been deemed unsafe and banned by the Food and Drug Administration in the U.S.

Instead of sharing those results with Canadian consumers, Health Canada kept them secret.

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And more seriously, when Health Canada finally did act, asking Apotex to stop importing drug ingredients from one of the Bangalore factories, the company simply ignored the order. Faced with a refusal to follow its directive, the department played along — neither suspending the company’s licence nor taking it to court.

On Tuesday, though, Ambrose was finally acting more like a bulldog than a lapdog, saying the trust between the department and Apotex had been “broken.” “Our government will not tolerate a failure by drug companies to meet their obligations to abide by Canada’s high safety and quality standards,” she said.

This is good news that should restore a small measure of confidence in our drug regulation system in Canada. But there are many aspects of this unfolding situation that still must be addressed:

We need to know that Health Canada will act aggressively and proactively on behalf of consumers. It’s entirely right that the Star and opposition parties in Parliament should keep the department on its toes by bringing shortcomings to the attention of the public. But ultimately it’s up to the department to address the systemic shortcomings that kept it so passive for so long in this situation.

Health Canada is not issuing a recall on drugs or drugs made with drug products from the two plants, saying that “no specific” safety issues have been identified with drugs already in pharmacies. But earlier investigations by the FDA at one of the Apotex factories in Bangalore found that staff were manipulating drug test data. How can consumers have confidence in these products?

The FDA posts results of inspections on its website so consumers can be informed. Health Canada, with the exception of one case, does not. Consumers need to be kept in the loop. The department must become more transparent.

Last week, before this week’s ban, Health Canada confirmed that Apotex would stop distributing drug products manufactured at one of its factories in Bangalore. But at that time it would not say which drugs were being quarantined. It should have. It took more information from the FDA — information that Ambrose said “puts into question Health Canada’s trust in the reliability of data” the plants must provide — for it to release the list this week.

Among them: a generic form of Viagra, the antibiotic azithromycin, and drugs used to treat hypertension, dementia, high blood pressure, asthma, convulsions and Lou Gehrig’s disease.

For its part, Apotex says the ban by Health Canada is “unwarranted,” and had said earlier that it is “absolutely confident in the safety and quality of all our products.”

Health Canada has taken an important first step to ensure drug safety compliance and more confidence in our regulatory system, which it oversees. Now it must move to boost consumer confidence — and protection — by posting the results of all drug manufacturer inspections on its website. It must also act immediately in future to ban any suspect drugs. Anything short of that is just dangerous.

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